Clearance Summary
Blood Tubing Lines for Hemodialysis AV06C-E received FDA 510(k) clearance under submission number K231589, sponsored by NIKKISO CO., LTD.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-07-28.
- Submission: K231589
- Applicant / Sponsor: NIKKISO CO., LTD.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2023-07-28
Classification & Regulation
This clearance is catalogued under FDA product code KOC and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.